MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that sharps coll side entry 5.4qt pearl 12/pk lids do not fit.This occurred on 12 occasions.The following information was provided by the initial reporter: material no: , batch no: 0308910.It was reported that the customer had an issue that the lids do not fit.
Additional Manufacturer Narrative
Investigation: the customer provided a box containing 12 sharps containers with the incorrect lids.The lids provided correspond with a completely different product which verifies the complaint.According to the dhr review process, the result showed there were no issues reported like incorrect lids issue during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like incorrect lids issue for the same part number throughout the last twelve months.The root cause of this failure was found to be omission error (the material was incorrectly feed to the finish goods machine and the inspection to the part number and label information was omitted).H3 other text.
Event or Problem Description
It was reported that sharps coll side entry 5.4qt pearl 12/pk lids do not fit.This occurred on 12 occasions.The following information was provided by the initial reporter: material no: 305425 batch no: 0308910 it was reported that the customer had an issue that the lids do not fit.

• Brand Name: SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11721085
• Report Number: 2243072-2021-01256
• Device Sequence Number: 11561547
• Product Code: FMI
• UDI-Device Identifier: 00382903054251
• UDI-Public: 00382903054251
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305425
• Device Lot Number: 0308910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1